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510(k) K760144

SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID by Oxford Laboratories, Inc. — Product Code DAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Haptoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
Review Panel
IM
Submission Type

Other clearances by Oxford Laboratories, Inc.

  • K780912 — ADJUSTABLE DISPENSOR (June 28, 1978)
  • K760148 — SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN (July 20, 1976)
  • K760079 — REAGENT, THYROXINE T4 (#210) (July 20, 1976)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)
  • K760147 — SERUM, IGM ANTI-HUMAN ACID (July 20, 1976)
  • K760146 — SERUM, IGA GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760078 — REAGENT, RIA TRIIODOTHYRONINE T3 (#200) (July 20, 1976)
  • K760145 — SERUM, IGG GOAT ANTI-HUMAN ACID (July 19, 1976)

Other clearances for product code DAD

  • K993480 — K-ASSAY HAPTOGLOBIN (November 24, 1999)
  • K972639 — TINA-QUANT HAPTOGLOBIN (January 9, 1998)
  • K964301 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (October 7, 1996)
  • K952593 — N/T PROTEIN CONTROL SY/L, M AND H (July 17, 1995)
  • K915829 — IL TEST(TM) HAPTOGLOBIN (HPT) (July 29, 1992)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K873866 — HAPTOGLOBIN (October 20, 1987)
  • K872717 — QM300 HAPTOGLOBIN ANTIBODY PACK (July 21, 1987)